The primary objective of this study is to determine the role of genital warts (GW) on Human Immunodeficiency Virus (HIV) acquisition among men who have sex with men (MSM) in Peru. The secondary objectives are to determine Human Papillomavirus (HPV) prevalence in HIV positive MSM in Peru, risk factors associated with GW, and the knowledge of HPV and HIV among MSM.

Persons with Human Immunodeficiency Virus (HIV) infection are at higher risk of becoming infected with the Human Papillomavirus (HPV) compared to those who are HIV negative. The contrary is also true: individuals infected with HPV may be more likely to acquire HIV; however, the role of the clinical manifestation of HPV - genital warts (GW) - on HIV acquisition is currently unknown. Few studies have shown that GW are independently associated with HIV acquisition.

The primary objective of this study is to determine the role of GW on HIV acquisition among MSM in Peru. The secondary objectives are to determine HPV prevalence in HIV positive MSM in Peru, risk factors associated with GW, and the knowledge of HPV and HIV among MSM. The specific aims of this study are:

To assess the knowledge of Peruvian MSM of the role of HPV in HIV infection.

The study will be conducted in the Gay Men's Community Health Center, Epicentro, the only center in Lima that specifically caters to men who have sex with men and sees a high burden of genital warts in their patient population. The study includes a population of 600 MSM (300 with recent or current genital warts). Baseline HIV serostatus will be done by rapid testing, and follow-up for HIV incidence will be done every 6 months over a two year time period. We will determine HPV status in HIV-positive participants and refer them for free highly active antiretroviral therapy (HAART) treatment. We will examine participants for GW presence and collect information on history of GW. A survey will be administered at each visit which examines changes in risk behaviors over time.

This novel study proposes to both measure the prevalence of GW in MSM presenting at a community clinic environment and prospectively measure HIV incidence in men with GW and those without GW. It will be the first study of its kind that we are aware of using HIV infection as an endpoint in men with and without GW and will help to better understand the relationship between genital warts and HIV infection among MSM in Peru.

Eligibility

Ages Eligible for Study:

18 Years to 40 Years

Genders Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Sampling Method:

Non-Probability Sample

Study Population

Community sample

Criteria

Inclusion Criteria:

Anatomical males 18-40 years of age,

Self-reported anal sex with another man within 12 months prior to enrollment,

Willing to provide informed consent for the collection of demographic and sexual behavior data, as well as blood for HIV and Syphilis testing, swabs of anal mucosa for HPV testing and urine for Chlamydia testing,

Resident of metropolitan Lima.

Exclusion Criteria:

Prior participation in an HPV vaccine clinical trial,

Prior participation in an HIV vaccine clinical trial,

Presence of a known immunodeficiency that increases risk of acquiring HIV.

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01387412